Comparative study on the effect of oral mucosal tea and green tea gel on Streptococcus mutans and lactobacilli saliva in adolescents aged 12 to 18 years
To conduct this study, 30 adolescents aged 12 to 18 years old, who themselves and their parents sign a informed consent form, are selected according to entry and exit criteria. A salivary specimen is sent to the laboratory to count the colony of Streptococcus mutans and lactobacillus. The randomization was performed based on the amount of Streptococcus mutans and lactobacilli saliva and individuals are randomly assigned into two groups of random numbers. . The goal is to measure the amount of these microorganisms at the beginning of the study in two groups. For two weeks, a mouthpiece group is given to another group of green tea gel. After the end of two weeks, a saliva sample is taken and a colony count is taken. After the washout period of 4 weeks, the first phase process is performed in two groups in reverse order. The results are analyzed by independent t-test and paired t-test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017090135652N2
Registration date:2017-09-25, 1396/07/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-25, 1396/07/03
Registrant information
Name
maryam hajahmadi
Name of organization / entity
Isfahan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3266 2236
Email address
maryam_hajahmadi@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study on the effect of oral mucosal tea and green tea gel on Streptococcus mutans and lactobacilli saliva in adolescents aged 12 to 18 years
Public title
Influence of Green Tea on the Prevention of Caries in Adolescents
Purpose
Prevention
Inclusion/Exclusion criteria
Adolescents aged 12 to 18 years who have signed the informed consent form and are considered systemically healthy by the individual and his or her parents. Do not eat xylitol chemically at least three weeks before and do not use during the study. They also received no systemic antibiotics and topical fluoride therapy for 4 weeks or more. Oral hygiene is good and brushing twice a day. Active dental caries (which have cavities and are symptomatic and have pain) and do not have periodontal disease and gingivitis. Exit criteria: Children who received systemic antibiotics and topical fluoride therapy 4 weeks ago, those with systemic disease, the presence of cavity caries or active and untreated periodontal disease, the presence of an orthodontic brace or fixed or movable prosthesis
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Faculty of Dentistry, Isfahan University of Medical Sciences,Hezarjerib street ,Isfahan
City
Isfahan
Postal code
Approval date
2017-01-27, 1395/11/08
Ethics committee reference number
396177
Health conditions studied
1
Description of health condition studied
dental caries
ICD-10 code
K00-K14
ICD-10 code description
K00-K14
Primary outcomes
1
Description
streptococcus mutans and lactobacillus
Timepoint
Before intervention
Method of measurement
microbiology and withculicativating bacteria
Secondary outcomes
1
Description
decrease or elimination of streptococcus mutans and lactobacillus
Timepoint
two weeks after intervention
Method of measurement
microbiology and with cultivating bacteria
Intervention groups
1
Description
Mouthwash and gel use
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan University of Medical Sciences, Faculty of Dentistry, Pediatrics Department
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research , Isfahan University of Medical Sciences
Full name of responsible person
Leila sarrami
Street address
Esfahan, Faculty of Dentistry, Department of Pediatrics
City
Esfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research , Isfahan University of Medical Sciences